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Alembic Pharmaceuticals Ltd. is a prominent Indian multinational pharmaceutical company headquartered in Vadodara, Gujarat. Established in 1907, it is one of the oldest pharmaceutical companies in India, originally starting as Alembic Chemical Works with a focus on producing tinctures and alcohol. Over the decades, it has grown into a vertically integrated organization involved in the research, development, manufacturing, and marketing of pharmaceutical products, including active pharmaceutical ingredients (APIs), branded formulations, and generic drugs.
We are HIRING!!
REGULATORY AFFAIRS
Position: Sr. Executive / Asst. Mgr./ Dy. Mgr
Location: Corporate Office-Vadodara
Job Criteria:
•B. Pharm or M. Pharm qualification having experience between 7 – 15 yrs. with dossier filling experience in MEXICO or ASEAN Country.
•Knowledge for review of quality documents like executed batch documents, method validation, change
•Good communication skill
Job Responsibility:
•Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision
•Manages electronic documents and creates electronic submissions in CTD format.
•Preparation and review of responses to authority questions during registration and product lifecycle.
•Keep track of assigned projects and follow-ups to ensure the Dossier is delivered as per set timeline/commitments.
•Designing, Reviewing & Approval of Artwork required for registration purposes.
•Dossier due diligence for products being in-licensed from other company
•Support in preparing the meeting materials as needed, eg, regulatory project status/submission/ approval information monthly, quarterly or yearly.
Interested professionals may share their CVs to <hrd@alembic.co.in> stating position code “RA-2025” in subject line
www.alembicpharmaceuticals.com
